BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONDASPACE

    MDR report key: 7735230 · Received July 31, 2018

    Report

    Report Number
    9710055-2018-00062
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Report Date
    September 20, 2018
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET SAS, PARC DE LIMÈRE, AVENUE DE LA POMME DE PI ORLÉANS CEDEX 2, FRANCE 45074. EXEMPTION # E2018005. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4). THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET SAS, PARC DE LIMÈRE, AVENUE DE LA POMME DE PI ORLÉANS CEDEX 2, FRANCE 45074 EXEMPTION # E2018005. GETINGE USA SALES, LLC. 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4). MAQUET SAS BECAME AWARE OF AN INCIDENT WITH SURGICAL LIGHT POWERLED DEVICE. IT WAS STATED THAT THE CAMERA DETACHED FROM THE LIGHT HEAD AND BECAME SUSPENDED ON WIRING. THERE WAS NO PATIENT INVOLVED HOWEVER IT WAS DECIDED TO REPORT THE EVENT IN ABUNDANCE OF CAUTION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE LIGHT-HEAD DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. IN THE TIME WHEN THE EVENT OCCURRED THE DEVICE WAS BEING USED FOR THE PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT THERE IS NO APPARENT INCREASE IN TREND WITH THE ISSUE AT HAND AND THAT THE REPORTED SCENARIO HAS NEVER LEAD, TO DATE, TO SERIOUS INJURY OR WORSE. THIS FAILURE OCCURS DUE TO TEARING OF THE HOUSING LOCATED ON 6 SCREWS. THE CONTRIBUTING FACTORS CAN BE EXCESSIVE STRESSES DURING THE MANIPULATION OF THE CAMERA.

    Description of Event or Problem · 0

    ON (B)(6) 2018 MAQUET SAS BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHT WITH ONDASPACE SPRING ARM. AS IT WAS STATED, THE CAMERA CONNECTED TO THE LIGHT HEAD BROKE. THE CIRCUMSTANCES OF THE ISSUE ARE UNKNOWN HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART FALLING COULD BE A SOURCE OF CONTAMINATION. (B)(4).

    Description of Event or Problem · 0

    MFG REFERENCE: (B)(4); TW # (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EXEMPTION # E2018005. (B)(4). THE ISSUE IS BEING INVESTIGATED. ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.

    Description of Event or Problem · 1

    REF- (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2018 MAQUET SAS BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHT WITH ONDASPACE SPRING ARM. AS IT WAS STATED, THE CAMERA CONNECTED TO THE LIGHT HEAD BROKE. THE CIRCUMSTANCES OF THE ISSUE ARE UNKNOWN HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART FALLING COULD BE A SOURCE OF CONTAMINATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578166 ONDASPACE LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    0
    1